Clinical Evaluation of Medasense Pain Monitor Performances

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medasense Biometrics Ltd
ClinicalTrials.gov Identifier:
NCT01631695
First received: October 24, 2011
Last updated: October 27, 2013
Last verified: October 2013
  Purpose

In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).

The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.


Condition
Surgery
Pain
Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist

Further study details as provided by Medasense Biometrics Ltd:

Primary Outcome Measures:
  • Changes in Medasense's non-invasive pain monitoring index in response to painful events. [ Time Frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion) ] [ Designated as safety issue: No ]
    outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.


Secondary Outcome Measures:
  • Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli [ Time Frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion) ] [ Designated as safety issue: No ]
    Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.

  • Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli [ Time Frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion) ] [ Designated as safety issue: No ]
    Outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.

  • Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs [ Time Frame: before versus after analgesic drug administration ] [ Designated as safety issue: No ]

    Outcome measures will be assessed one minute before administration of analgesic drug, and will be compared to measures taken one minute after.

    Participants will be followed for the duration of surgery and Postoperative Recovery.



Enrollment: 96
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the visual analog scale (VAS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.

During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. Therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.

In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for elective surgeries under general anesthesia, healthy or suffering from minor chronic diseases (ASA I-II)

Criteria

Inclusion Criteria:

  • ASA physical status 1-2
  • Elective surgery under general anesthesia
  • Baseline blood pressure < (170\100 mmHg), heart rate < 100 bpm

Exclusion Criteria:

  • Pregnancy or lactation
  • History of severe cardiac arrhythmias
  • Presence of any neuromuscular or neurological disease
  • Use of central nervous system (CNS) -active medications
  • Abuse of alcohol or illicit drugs
  • History of mental retardation or any mental disease
  • Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
  • Use of a α or β-adrenergic antagonist or anticholinergics
  • Allergy to any of the drugs to be used during surgery
  • Use of regional anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631695

Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Medasense Biometrics Ltd
Investigators
Principal Investigator: Ruth Edry, MD Department of Anesthesiology, Rambam Health Care Campus
  More Information

Publications:
Responsible Party: Medasense Biometrics Ltd
ClinicalTrials.gov Identifier: NCT01631695     History of Changes
Other Study ID Numbers: Medasense002, 0281-09-RMB
Study First Received: October 24, 2011
Last Updated: October 27, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014